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Virtual Reality-Based Mirror Therapy and FES-Cycling in Stroke Rehabilitation

24. Juni 2026 aktualisiert von: Ezgi Aydın, Ankara City Hospital Bilkent

Comparison of Virtual Reality-Based Mirror Therapy and Functional Electrical Stimulation-Assisted Cycling for Upper Extremity Rehabilitation After Stroke: A Randomized Controlled Trial

This randomized controlled, assessor-blinded study aimed to compare the effects of virtual reality-based mirror therapy (VRBMT) and functional electrical stimulation-assisted cycling (FES-cycling) when combined with conventional rehabilitation on upper extremity recovery in patients with stroke.

Participants with first-ever stroke, unilateral hemiplegia, and upper extremity impairment within six months after stroke onset were randomly assigned to one of three groups: conventional rehabilitation alone, conventional rehabilitation plus VRBMT, or conventional rehabilitation plus FES-cycling.

All participants received a four-week rehabilitation program. Upper extremity motor function, functional independence, use of the affected upper extremity in daily activities, and quality of life were assessed before and after the intervention.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

Stroke frequently results in upper extremity motor impairment, leading to limitations in activities of daily living and reduced quality of life. Although conventional rehabilitation is the standard approach for improving motor recovery after stroke, technology-assisted rehabilitation methods have been developed to enhance neuroplasticity and functional outcomes.

Virtual reality-based mirror therapy provides visual feedback and aims to stimulate motor relearning mechanisms, whereas functional electrical stimulation-assisted cycling combines repetitive movement with electrically induced muscle activation to support motor recovery.

This randomized controlled, assessor-blinded study was designed to compare the additional effects of these two technology-assisted rehabilitation approaches when combined with conventional rehabilitation in patients with post-stroke upper extremity impairment.

Participants were randomly assigned to three parallel treatment groups. Clinical assessments were performed before and after completion of the rehabilitation program by an assessor blinded to group allocation.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

60

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Türkei (türkiye)
    • Ankara
      • Ankara, Ankara, Türkei (türkiye), 06800
        • Ankara Bilkent City Hospital, Physical Medicine and Rehabilitation Hospital

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

Inclusion Criteria:

  • Age older than 18 years
  • First-ever stroke
  • Unilateral hemiplegia
  • Time since stroke onset ≤6 months
  • Upper extremity Brunnstrom recovery stage between 1 and 4
  • Modified Ashworth Scale score <3 in the affected upper extremity
  • Ability to maintain sufficient sitting balance

Exclusion Criteria:

  • Visual impairment
  • Contraindication to electrical stimulation, including cardiac pacemaker implantation
  • Cognitive impairment (Mini-Mental State Examination score <25)
  • Severe aphasia preventing completion of clinical assessments
  • Presence of additional neurological disorders, including Parkinson's disease, Alzheimer's disease, multiple sclerosis, neuromuscular junction disorders, motor neuron disease, or peripheral nerve lesions
  • Neglect syndrome
  • Orthopedic conditions affecting upper extremity function, including amputation or joint contracture
  • Severe cardiac disease
  • Uncontrolled hypertension
  • Epilepsy
  • Psychiatric disorders such as schizophrenia or bipolar disorder
  • Pregnancy or suspected pregnancy
  • Acute deep vein thrombosis or thrombophlebitis
  • Local infection at the treatment site

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Single

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Aktiver Komparator: Conventional Rehabilitation
Participants received a conventional rehabilitation program consisting of neurophysiological exercises, range of motion exercises, strengthening exercises, stretching exercises, balance and coordination training, and ambulation training for 40 minutes per day, five days per week, for four weeks.
Sonstiges: Conventional Rehabilitation
A conventional rehabilitation program including neurophysiological exercises, range of motion exercises, strengthening exercises, stretching exercises, balance and coordination training, and ambulation training.
Experimental: Virtual Reality-Based Mirror Therapy
Participants received conventional rehabilitation combined with virtual reality-based mirror therapy using the Neuroforma system. Virtual reality-based mirror therapy was administered for 15 minutes per day, five days per week, for four weeks.
Sonstiges: Conventional Rehabilitation
A conventional rehabilitation program including neurophysiological exercises, range of motion exercises, strengthening exercises, stretching exercises, balance and coordination training, and ambulation training.
Gerät: Virtual Reality-Based Mirror Therapy
Virtual reality-based mirror therapy was performed using the Neuroforma system. The intervention provided visual feedback to create an illusion of movement of the paretic upper extremity and aimed to support motor relearning.
Experimental: Functional Electrical Stimulation-Assisted Cycling
Participants received conventional rehabilitation combined with functional electrical stimulation-assisted cycling using the RT-300 system. FES-cycling therapy was administered five days per week for four weeks.
Sonstiges: Conventional Rehabilitation
A conventional rehabilitation program including neurophysiological exercises, range of motion exercises, strengthening exercises, stretching exercises, balance and coordination training, and ambulation training.
Gerät: Functional Electrical Stimulation-Assisted Cycling
Functional electrical stimulation-assisted cycling was performed using the RT-300 system. Electrical stimulation was applied to targeted upper extremity muscles during cycling movements to facilitate repetitive motor activity.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in Upper Extremity Motor Function Assessed by the Fugl-Meyer Assessment
Zeitfenster: Baseline and 4 weeks
Upper extremity motor function was evaluated using the upper extremity section of the Fugl-Meyer Assessment (FMA-UE). The FMA-UE assesses motor impairment of the affected upper extremity, with total scores ranging from 0 to 66. Higher scores indicate better upper extremity motor function. Change from baseline to the post-treatment assessment was calculated as the post-treatment score minus the baseline score.
Baseline and 4 weeks

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in Motor Recovery Assessed by the Brunnstrom Recovery Stages
Zeitfenster: Baseline and 4 weeks
Motor recovery was assessed using the Brunnstrom Recovery Stages. The upper extremity and hand stages were evaluated separately. Scores range from stage 1 to stage 6, with higher stages indicating better motor recovery.
Baseline and 4 weeks
Change in Functional Independence Assessed by the Functional Independence Measure
Zeitfenster: Baseline and 4 weeks
Functional independence was assessed using the Functional Independence Measure (FIM). The scale evaluates motor and cognitive aspects of daily functioning. Total scores range from 18 to 126, with higher scores indicating greater functional independence.
Baseline and 4 weeks
Change in Upper Extremity Use in Daily Activities Assessed by the Motor Activity Index-28
Zeitfenster: Baseline and 4 weeks
Functional use of the affected upper extremity during activities of daily living was assessed using the Motor Activity Index-28 (MAI-28). Total scores range from 0 to 28, with higher scores indicating better use of the affected upper extremity.
Baseline and 4 weeks
Change in Quality of Life Assessed by the Short Form-36 Health Survey
Zeitfenster: Baseline and 4 weeks
Health-related quality of life was assessed using the Short Form-36 Health Survey (SF-36), which includes eight domains evaluating physical and mental health. Each domain score ranges from 0 to 100, with higher scores indicating better quality of life.
Baseline and 4 weeks

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Ankara City Hospital Bilkent

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

1. Mai 2021

Primärer Abschluss (Tatsächlich)

15. Februar 2023

Studienabschluss (Tatsächlich)

28. Februar 2023

Studienanmeldedaten

Zuerst eingereicht

18. Juni 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

18. Juni 2026

Zuerst gepostet (Tatsächlich)

24. Juni 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

26. Juni 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

24. Juni 2026

Zuletzt verifiziert

1. Juni 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • AYBU-26379996-55

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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